Acronym

TNT

Study hypothesis

To determine whether there is greater activity for carboplatin than a taxane standard of care (docetaxel) in women with oEstrogen Receptor-Progesterone Receptor-Human Epidermal growth factor Receptor 2 (ER-PR-HER2) breast cancer. The trial aims to recruit between 350 and 450 patients.

Ethics approval

East London and the City Research Ethics Committee 1, 11/06/2007

Study design

Phase III multicentre randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Metastatic or recurrent locally advanced disease

Intervention

Arm A: Carboplatin area under the concentrationtime curve (AUC) six, every three weeks for six cycles (18 weeks)Arm B: Docetaxel 100 mg/m^2, every three weeks for six cycles (18 weeks)

Cross over to alternative treatment on progression.

Intervention type

Drug

Phase

Phase III

Drug names

Carboplatin, docetaxel

Primary outcome measures

Response will be evaluated after three and six cycles of chemotherapy using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, with appropriate clinical assessment and radiological investigations.

Secondary outcome measures

1. Time to progression: this will be defined according to RECIST criteria and will be measured from the start of treatment until the confirmation of progression2. Progression free survival: this will be defined according to RECIST criteria and will be measured from the start of treatment until the confirmation of progression or death. Response to second line therapy on progression will be assessed using RECIST criteria as described for the primary endpoint3. Time to treatment failure: this will be defined as time from randomisation to discontinuation of protocol treatment for any reason, or progression of disease as defined by RECIST4. Overall survival: this will be defined as time from randomisation until death from any cause in the intention to treat population5. Toxicity will be assessed throughout the treatment period using the National Cancer Institute Common Terminology Criteria for Adverse Events version three (NCI CTCAE v3.0).

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

350 - 450 patients

Participant exclusion criteria

1. Original primary tumour or subsequent relapse known to be positive for any of ER, PR, or HER2 receptors2. Patients with inoperable locally advanced disease suitable for local radiotherapy or an anthracycline containing regimen3. Patients unfit for chemotherapy or those with neuropathy greater than grade one (sensory or motor)4. Known allergy to platinum compounds or to mannitol5. Known sensitivity to taxanes6. Previous exposure to a taxane in adjuvant chemotherapy within 12 months of trial entry7. Previous treatment with a taxane for recurrent/metastatic disease8. Previous treatment with a platinum chemotherapy drug9. LFTs: abnormal bilirubin (greater than ULN), AST and/or ALT greater than 3 x ULN and Alkaline Phosphatase greater than 5 x ULN (or an isolated elevation AST/ALT of greater than or equal to 5 x ULN)10. Patients with a life expectancy of less than three months11. Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease free interval of at least ten years12. Patients with bone limited disease 13. Other serious uncontrolled medical conditions or concurrent medical illness likely to compromise life expectancy and/or the completion of trial therapy14. Pregnant, lactating or potentially childbearing women not using adequate contraception (documentation of a negative serum Human Choronic Gonadotropin [HCG] pregnancy test should be available for pre-menopausal women with intact reproductive organs, or women less than two years after the menopause. Fertile women and their partners must use a medically acceptable contraceptive throughout the treatment period and for six months following cessation of treatment. Subjects must be made aware before entering the trial of the risk in becoming pregnant)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/03/2017: The overall trial end date was changed from 21/03/2016 to 31/07/2018.
17/04/2014: The overall trial end date was changed from 16/01/2014 to 21/03/2016.
18/01/2008: The overall trial start and end dates of the trial were updated. The previous overall trial start and end dates:
1. Overall trial start date: 01/10/2007
2. Overall trial end date: 01/10/2013
The previous sponsor of this trial was the 'Institute of Cancer Research and Guy's and St Thomas's NHS Foundation Trust (UK)'. For details of the current sponsor, please see the sponsor section.